Fairly or not, the U.S. Food and Drug Administration has sometimes been depicted as an impediment in the development of new drugs and treatments for the various illnesses that afflict humans.
Perhaps the bureaucracy that hampers so many government agencies is a reason, or maybe the FDA is cautious to a fault.
In any case, the agency deserves credit for its support of an experimental program intended to match cancer patients with drugs that best fit the gene profile in their tumors. The FDA has agreed to consider approving medicines based on the study’s results.
The study, which began Monday, is called Lung-MAP, though plans exist for similar studies for colon and breast cancer. Lung-MAP will involve up to 1,000 patients a year who have advanced squamous cell lung cancer, a type that is common yet hard to treat. Squamous cell lung cancer has more than twice the genetic mutations as most forms of cancer. According to the Associated Press, participants will be screened for mutations in more than 200 cancer-related genes and then assigned to one of a handful of groups depending on their tumor “biomarkers.” The least this will do is minimize the number of patients who are exposed to ineffective treatments.
Each group will test an experimental medicine, with the possibility that drugs will be added or withdrawn based on how they perform.
A handful of drug companies, including Amgen, Genentech, Pfizer, and AstraZeneca, are participating, as are several hundred U.S. hospitals, the National Cancer Institute and other organizations.
Lung cancer — all cancer — is insidious, and although this study does not come with guarantees, it’s almost certain to advance the research in ways that will help a wider variety of cancer patients.
“There’s something for everyone, and we’ll get answers faster” on which drugs work best, said Ellen Sigal, chair and founder of Friends of Cancer Research in Washington, D.C. That’s particularly important because getting new forms of treatment that can help more patients is one of the program’s key goals.
Dr. Roy Herbst, chief of medical oncology at the Yale Cancer Center, is cautiously optimistic about Lung-MAP and the effort to match patients with experimental drugs. “Nothing like this has ever been done before,” he said.
For cancer patients and their loved ones, any progress will be greatly appreciated.